William Moss

Development Engineer @Exstent

Tewkesbury, GB

Perform design and development tasks for all engineering aspects of the design and production of the ExoVasc Personalised External Aortic Root Support implant.Detailed Responsibilities:1) Performs design and development tasks relating to the technical performance of the product, the specification of the materials used in its construction, the associated verification and validation activities and maintenance of the Technical File.2) Provides technical support in the development and improvement of processes followed in all stages of the manufacture of the implant, including the performance of process validation testing.3) Maintains familiarity and contact with the surgical community worldwide to follow current trends in surgical approaches and their relevance to the clinical application of the product4) Reviews and collates clinical data on the use of the product for use in PMS and development activities5) Provides technical support and training to distributors and sales staff6) Carries out development activities associated with exploring new clinical applications7) Supports manufacture with the process of manipulation of patient scan data to produce resampled aortic image data suitable for computer modelling8) Supports manufacture, with the application of the CAD modelling software and the review of the CAD model9) Provides support to the development and maintenance of software, including performing software validation10) Provides technical input on the operation and maintenance of the cleanroom (ISO Class 5) and associated equipment11) Works with the Quality and Regulatory Affairs personnel to produce Quality Management System procedures that are compliant with relevant standards, including in particular ISO 13485, FDA, and MDSAP requirements.12) Provides technical support to ensure that the operation of customer and product history files are correctly maintained13) Provides technical training to relevant personnel on all production processes.